Observation of HIV-Infected Children Receiving Protease Inhibitor and Reverse Transcriptase Inhibitor

Completed

• Conditions: HIV Infection

• Registration Number: NCT00001826
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This study will continue to follow children who participated in an earlier National Cancer Institute trial of HIV treatment with a protease inhibitor. Children in this study will receive a combination of at least three drugs that include at least one protease inhibitor and one reverse transcriptase inhibitor.

The study will examine to what extent these drugs can restore immune function in HIV-infected children and over what length of time. It will look at changes in the amounts of virus and the specific types of immune cells in the body over the 96-week trial period. It will also examine patients' immune system response to influenza and tetanus vaccinations.

The children will either continue to receive the anti-HIV drugs they have been taking, or their medicines will be changed to a different combination of protease inhibitor and reverse transcriptase inhibitor. Before and during the study, patients will undergo various tests, including a physical examination, blood tests and chest X ray, immune response tests, CT scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may be done to collect white blood cells. In this procedure, whole blood is drawn similar to donating blood, the white cells are separated out by a machine, and the red cells are returned to the body.

Detailed Description

This study will evaluate the extent of immunoreconstitution in children receiving combination antiretroviral therapy that includes a protease inhibitor and reverse transcriptase inhibitors. The children who will be evaluated and followed in this study are those who have previously been studied on other protease inhibitor-containing anti-HIV protocols within the HIV and AIDS Malignancy Branch. This study will provide a mechanism to assess the long-term immunologic changes of potent combination therapy in this unique population and to relate this to the virologic changes. A total of 50 HIV-1 infected children will be studied. The children enrolled in this protocol will either continue their current combination of protease inhibitor and reverse transcriptase therapy or, if deemed clinically appropriate, will be changed to a new, best available combination of protease inhibitor and reverse transcriptase inhibitors. Long-term immunoreconstitution, defined as the repopulation of naive CD4+T lymphocytes, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+T cells and by the ability of patients to mount new helper T cell responses after immunization with influenza and tetanus toxoid. Expansion of T cell receptor will also be explored in subsets of enrolled patients. In addition, unforeseen toxicities attributable to the use of combination antiretroviral therapy have been recognized and described in adult patients. This study will evaluate abnormalities in lipid and glucose metabolism, changes in the distribution of body fat, and surrogate markers of cardiovascular disease risk in this cohort of pediatric patients.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Status Verified: 2006-05
• Study Completion: 2006-05
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Cancer Institute (NCI); 🇺🇸 Bethesda, Maryland, United States